Pasithea says tablet PK exposure increases proprtionally with dose increase

Pasithea Therapeutics (KTTA) announced tablet PK data from ongoing Phase 1/1b open-label study evaluating PAS-004 in adult patients with neurofibromatosis type 1 with symptomatic and inoperable, incompletely resected, or recurrent plexiform neurofibromas. PAS-004 has demonstrated in the tablet formulation (4mg and 8mg cohorts): Linear PK and dose-proportionality; PK curve with Cmax/Cmin ratio less than2, with Cmax and Cmin above the IC50 from the cellular assay; Long half-life of approximately 57 hours. Cohort 1 (4mg tablet) has demonstrated: AUC: 1,120 ngh/mL; Cmax: 58.1 ng/mL; Cmin: 37.6 ng/mL. Cohort 2 (8mg tablet) has demonstrated: AUC: 2,290 ngh/mL; Cmax: 118 ng/mL; Cmin: 75.4 ng/mL. Dose normalized exposures following once daily administration of PAS-004 tablets were approximately 3-fold higher than those following administration with the capsule formulation, resulting in the 8mg tablet area under the curve and Cmax being slightly greater than those of the 22mg capsule. The tablet formulation has demonstrated less patient variability and a similar Tmax range when compared to the capsule formulation. This is consistent with the pre-clinical evaluation of the two formulations in the dog toxicology studies.